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Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00710515
First received: July 2, 2008
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach


Condition Intervention Phase
Melanoma
Malignant Melanoma
Drug: AZD6244
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess whether food influences the rate and extent of AZD6244 absorption [ Time Frame: Day 1 and Day 10 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food [ Time Frame: Day 1, 2, 3, 8, 9, and 10 ] [ Designated as safety issue: Yes ]
  • To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies [ Time Frame: screening to 30 day post last dose ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
with food
Drug: AZD6244
75mg
Experimental: 2
without food
Drug: AZD6244
75mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to eat a high fat breakfast within a 30-minute period
  • Advanced cancer which is refractory to standard therapies, for which no standard therapies exist
  • WHO or ECOG performance status 0-2 (those with performance status 2 must have been stable with no deterioration for over 2 weeks)

Exclusion Criteria:

  • Any radiotherapy or chemotherapy within 21 days prior to starting the study treatment (not including palliative radiotherapy at focal sites).
  • Any evidence of severe or uncontrolled systemic disease (eg., severe hepatic impairment, severe renal impairment, uncontrolled diabetes, acute uncontrolled infection) or current unstable or uncompensated respiratory or cardiac conditions or peripheral vascular disease including diabetic vasculopathy.
  • Refractory nausea and vomiting, chronic GI diseases (eg., inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710515

Locations
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Maastricht, Netherlands
United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Headington, United Kingdom
Research Site
London, United Kingdom
Research Site
Oxford, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rajesh Chopra AstraZeneca
Principal Investigator: Jan Schellens Maastricht
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00710515     History of Changes
Other Study ID Numbers: D1532C00020, 2007-004456-37 EudraCT Number
Study First Received: July 2, 2008
Last Updated: August 12, 2014
Health Authority: Netherlands: Medicines Evaluation Board (MEB)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Melanoma
Phase I
AZD6244

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 27, 2014